Re-evaluation Decision RVD2019-03, Fluroxypyr (present as ester) and Its Associated End-use Products

Pest Management Regulatory Agency
8 March 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-3E-PDF (PDF Version - 237 KB)

Table of Contents

• Re-evaluation Decision
• Outcome of Science Evaluation
• Regulatory Decision for Fluroxypyr
• Next Steps
• Other Information
• Appendix I Registered Fluroxypyr Products as of October 2018
• Appendix II Comments and Responses
• Appendix III Revised Label Amendments for End-use Products Containing Fluroxypyr
• Appendix IV References

Re-evaluation Decision

Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Fluroxypyr is a post-emergent herbicide that offers control of annual broadleaved weeds in small grain cereals, rangeland, permanent pasture, industrial and other non-cropland areas. It is applied with both ground and aerial equipment. Currently registered products containing fluroxypyr are listed in Appendix I.

This document summarizes the final regulatory decision^Footnote 1 of fluroxypyr, and all pest control products containing fluroxypyr registered in Canada are subject to this final re-evaluation decision. Prior to finalizing this decision, Health Canada published the Proposed Re-evaluation Decision PRVD2017-11, Fluroxypyr (present as ester) and Its Associated End-use Products, for a 90-day consultation^Footnote 2. One comment was received during the consultation process, and it was taken into consideration for this final regulatory decision. The comment did not result in changes to the proposed decision of fluroxypyr. Therefore, this final decision is consistent with the proposed re-evaluation decision stated in PRVD2017-11. Appendix II of this document summarizes the comment received during consultation period and provides the PMRA's response.

A reference list of all data used as the basis for the re-evaluation decision is included in Appendix IV.

Outcome of Science Evaluation

Health risks from the use of fluroxypyr and its associated end-use products have been shown to be acceptable for all uses, when used according to current label directions. The environmental risks associated with the use of fluroxypyr and its associated end-use products are considered to be acceptable when used according to the revised label directions (updated buffer zones). Fluroxypyr has value with respect to weed management program for cereal (wheat, barley, and oats) and seed production of forage grasses, and for the management of pasture, rangeland, and industrial non-crop areas.

Regulatory Decision for Fluroxypyr

Health Canada has completed the re-evaluation of fluroxypyr. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing fluroxypyr is considered to be acceptable. An evaluation of available scientific information found that uses of fluroxypyr products meet current standards for protection of human health and/or the environment when used according to the conditions of registration, which include the required label updates summarized below. Refer to Appendix III for details.
Human Health Label Updates

• Updated restricted-entry interval; and
• Updated label statements to minimize bystander exposure from spray drift.

Environmental Label Updates

• Updated buffer zones;
• Updated environmental hazard label statements; and
• Updated storage label statements.

Next Steps

To comply with this decision, the required label updates must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Products containing fluroxypyr that are registered under the authority of the Pest Control Products Act are listed in Appendix I.

Other Information

Any person may file a notice of objection^Footnote 3 regarding this decision on fluroxypyr within 60 days from the date of publication of this re-evaluation decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service.

Appendix II Comments and Responses

The PMRA received the following comment relating to the Proposed Re-evaluation Decision PRVD2017-11, Fluroxypyr (present as ester) and Its Associated End-use Products. The comment received is presented below, in conjunction with the PMRA response.

Comment Related to Restricted-Entry Interval (REI) Language

Comment

The comment supported the requirement of a 12-hour REI for crop uses and requested that the PMRA maintain the current REI of "Until sprays have dried" for all non-crop uses.

PMRA Response

The PMRA agrees with the comment and clarifies the REI requirement for crop (12-hour REI) and non-crop uses (until sprays have dried). The amended label statements are included in Appendix III.

Appendix III Revised Label Amendments for End-use Products Containing Fluroxypyr

The label amendments presented below do not include all label requirements for individual end-use products, such as first aid statements, disposal statements, precautionary statements, and supplementary protective equipment. Information on labels of currently registered products should not be removed unless it contradicts the label statements provided below.

I) Under PRECAUTIONS, the following statements must be included:

II) The following statements must be included in a section entitled ENVIRONMENTAL PRECAUTIONS:

III) For products containing aromatic petroleum distillates, the following statement must be included in a section entitled ENVIRONMENTAL PRECAUTIONS:

IV) In a section entitled STORAGE, the following must be removed:

V) The following statement must be included in a section entitled STORAGE:

VI) The following statements must be included in a section entitled DIRECTIONS FOR USE:

VII) The following buffer zone statements must be included on the label:

Buffer Zone Related Label Statements Required for End-Use Product ARY 0548-019 Herbicide (PCP# 30580):

Add to DIRECTIONS FOR USE:

Buffer zones:

Buffer Zone Related Label Statements Required for Fluroxypyr End-Use Products Requiring Applications with Spray Droplets of ASAE Medium Classification:

Add to DIRECTIONS FOR USE:

Buffer zones:

Appendix IV References

I) Information Considered in the Re-evaluation not Submitted by the Registrants

II) Information Considered in the Re-evaluation Submitted by the Registrants